The present invention generally relates to methods and devices for the calibration of a bodily fluid sampling device, and more specifically, but not exclusively, concerns a control solution packet for delivery of a control solution to a bodily fluid sampling device.
The need for simple methods to determine the biological and chemical constituents in bodily fluids has increased as point of care testing has gained in popularity. A common application is the self-monitoring of blood glucose concentrations by patients with diabetes. These patients frequently administer insulin or take other therapeutic actions based on the test results. As testing is generally recommended multiple times daily and may occur in any setting, an easy to use and relatively inexpensive method to accomplish this task is required. Self-administered bodily fluid sampling devices, such as glucose meter devices, are typically used to perform such testing.
Bodily fluid monitoring devices can collect a blood sample, or other bodily fluid samples, in a number of ways. For instance, in one less traumatic technique, a glucose monitoring device having a small hollow needle or lancet is used to pierce the patient's skin. The device is pressed against the skin to force a small sample of the monitored bodily fluid, such as blood or interstitial fluid, up the needle and into a testing area of the device. Once in the testing area, the fluid sample can be analyzed using any one of a number of techniques, such as using a chemically reactive test strip, measuring the sample's electrical properties or measuring the optical properties of the sample (i.e., infrared analysis). Examples of such devices are disclosed in U.S. Pat. Nos. 6,203,504, issued to Latteral et al. on Mar. 20, 2001, and 6,152,889, issued to Sopp et al. on Nov. 28, 2001, which are hereby incorporated by reference in their entirety.
With the advent of home testing, the bodily fluid sampling device and associated disposables have to be periodically tested to ensure that both are providing accurate test results. Typically, the bodily fluid sampling device is calibrated by loading a calibration strip into the device. Inaccurate calibration readings may result when the user fails to follow the proper testing procedures.
If the user feels that the disposable test strips are not providing an accurate reading, then the accuracy of the disposable test strips can be tested utilizing a control solution that has a known value. For example, a liquid control solution may be applied to a test strip which is then inserted into the meter. In order to utilize a control solution, the user is therefore required to perform a plurality of steps, any of which can lead to the introduction of errors in the control solution testing, thereby potentially leading to erroneous results. Moreover, by not calibrating the device in the manner in which it is used, problems associated with the operation of the device, such as contamination, may remain undetected.
Therefore, there is a need for methods and devices that enable a user to easily and quickly perform a control test on a bodily fluid sampling device and that reduces or eliminates any chance of error occurring during the control test.